Memantine Hydrochloride Tablets Receives US FDA MA approval

2020-04-28 09:51
Ningbo Shuangcheng Pharmaceutical Co., Ltd. ("Ningbo Shuangcheng"), a holding subsidiary of Hainan Shuangcheng Pharmaceutical Co., Ltd. ("the company") recently received notice from the U.S. Food and Drug Administration ("FDA") that the ANDA for Memantine Hydrochloride Tablets that has been transferred to Ninbgbo Shuangcheng from Ningbo Shouzheng Pharmaceutical Research Co., Ltd. ("Ningbo Shouzheng") has obtained the MA approval of FDA.
The FDA has reviewed the ANDA for Memantine Hydrochloride Tablets and the approval indicates the comprehensiveness and scientificity of the ANDA of the product, and that the equivalent bioequivalence of the product with that of the RLD, Namenda. The product is used for Treatment of moderate to severe dementia of the Alzheimer’s type.
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